MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number	9-TV45X45-12F-080
Medical Device Problem Codes	Material Invagination (1336); Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 22mm amplatzer amulet left atrial appendage occluder was selected for implant on (b)(6) 2024 using a 12f amplatzer torqvue 45x45 delivery sheath.During the procedure, several attempts were made to attach the loading tube to the delivery sheath for occluder insertion.Upon the third attempt it was noted that the internal cuff of the loading tube appeared to be invaginated, and the plastic of the threads were deformed.Both the occluder and delivery sheath were replaced with a new 22mm amplatzer amulet left atrial appendage and 12f amplatzer torqvue 45x45 delivery sheath.The patient experienced excessive bleeding due to the delay in attaching the loader to the delivery sheath.One unit of blood was transfused to the patient post-procedure.The patient status was stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device difficult to setup or prepare, material deformation and invagination, and hemorrhage was reported.The device was returned to abbott for investigation.The investigation found that the delivery sheath had multiple kinks throughout the tubing and the hub on the delivery sheath had significant damage, which precluded using it to perform functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported device difficult to setup or prepare could not be conclusively determined.The cause of the material deformation and invagination appears to be a cascading effect of multiple connection attempts.The cause of the reported hemorrhage appears to be related to procedural complication.The unexpected medical intervention was a result of case-specific circumstance as blood transfusion was administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20071623
• Report Number: 2135147-2024-04181
• Device Sequence Number: 6395771
• Product Code: DQY
• UDI-Device Identifier: 05415067025883
• UDI-Public: (01)05415067025883(17)260630(10)9152760
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: 9-TV45X45-12F-080
• Device Lot Number: 9152760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male